A Trial of One-week on/One-week Off Temozolomide Versus Continuous Dose-Intense Temozolomide in Patients With Glioblastoma Multiforme at First Relapse
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|ClinicalTrials.gov Identifier: NCT02330991|
Recruitment Status : Unknown
Verified January 2015 by Junping Zhang, Beijing Sanbo Brain Hospital.
Recruitment status was: Not yet recruiting
First Posted : January 5, 2015
Last Update Posted : January 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Temozolomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
Experimental: Arm1 ,one-week on/one-week off regimen
One-week on/one-week off regimen is administered for 12 cycles of 28 days. Arm 1 receives temozolomide 150 mg/m2 daily during days 1 to 7 and 15 to 21 of each cycle.Treatment will continue until tumor progression, development of excessive toxicity, withdrawal of consent, or completion of 12 cycles.
Other Name: Temodal
Experimental: Arm 2,continuous dose-intense regimen
Continuous dose-intense regimen is administered for 12 cycles of 28 days .Arm 2 receives temozolomide 50mg/m2 daily during days 1 to 28 of each cycle. Treatment will continue until tumor progression, development of excessive toxicity, withdrawal of consent, or completion of 12 cycles.
Other Name: Temodal
- Progress-Free Survival at 6 months (PFS6) [ Time Frame: 6 months ]
- Overall Survival(OS) [ Time Frame: 2 years ]
- Progression free survival [ Time Frame: 2 years ]
- Objective Response Rate [ Time Frame: up to 52 weeks ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330991
|Contact: Junping Zhang, MDfirstname.lastname@example.org|
|Principal Investigator:||Junping Zhang, MD||Beijing Sanbo Brain Hospital|